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mpreorder

08/31/17 10:42 PM

#31847 RE: Meishairwin #31835

Miesh - Sorry, but I most certainly DID consider the delays. The EU must, lets put that in capitals, shall we? MUST respond within 6 months. Anticipated delays come in the form of 2 "time outs" that can be up to 3 months each. So max time is 1 year. Your insistence on this point is a bit baffling. Do you have any other reason to believe what you state other than "the likelihood of delays" ??
Also, you haven't answered my very nicely worded question about the run up between submission and the delivery of an answer.

Easymoneyman00

08/31/17 11:06 PM

#31851 RE: Meishairwin #31835

Why would there be so many delays? I would think so many women that need our vaccines will die waiting on treatments if the EMA and the FDA try and delay our treatments to these patients. 21st Century Cures Act and EMA need be ready to pull the trigger on treatments that fill a unmet need in HPV Metastatic Cervical Cancer for end stage cancer patients.